Sr. LIMS Administrator - Philadelphia, PA | Biospace
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Sr. LIMS Administrator

MedImmune, LLC

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Location:
Philadelphia, PA
Posted Date:
8/18/2017
Position Type:
Full time
Job Code:
R-011150
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Location:
Philadelphia, Pennsylvania, United States
Job reference: R-011150
Posted date: Aug. 01, 2017

If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a QC Applications Analyst/Sr. Analyst in Red Lion PA, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Major Duties and Primary Activities:

Senior Application Analyst

Manage the day-to-day activities and application administration of QC Computerized systems, such as LIMS, including LIMS change control procedures.

Perform application administration tasks for QC computerized systems.

Manage the QC system interface with other MedImmune enterprise systems such as SAP. Responsible for developing plans with OIS and IT to link instruments with LIMS.  Aid in the development of the QC department information systems to aid in managing projects.

Liaison between QC and the Validation group with relation to software/computer systems validation.  Liaison between QC and IT with relation to all software/computer applications (networkability).

Liaison between QC and OIS in maintaining the LIMS and MIMS (when available). 

Facilitate and coordinate training of new and existing LIMS users, prepare training materials as necessary.

Responsible for all computer-based systems in QC including software upgrades, system management, cGMP compliance, etc.  Primary responsibility for computer-related VSCRs, NCs and CAPAs. This includes working with QA to generate them, review them and gain approval.

Responsible for QC software upgrades, including software for various instrumentation used in the lab. Work with OIS in implementation of corporate changes to corporate systems such as LIMS, MIMS, etc.

Work with IT for all networking requirements when new instrumentation is purchased. Work with IT and OIS on LIMS outages and ensure timely return to service.

Support QC information system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement.

Application Specialist

Performs duties of Senior Application Analyst, plus the following:

 Monitors QC computerized systems to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11.

Responsible for identifying process improvements and coordinating implementation of new processes in their functional area.

Maintains up to date familiarity with all applicable corporate and regulatory guidelines with respect to their functional area.

Coordinates with other departments (such as QA, QC, MS&T) to gather all required information and documentation in relation to process improvement, implementation and/or investigations.

Represents QC, as needed, during meetings, communicates and tracks all follow-up items through to completion.

Senior Application Specialist

Performs duties of Application Specialist, plus the following:

Plans and leads QC information system internal and cross-functional projects.

Serves as subject matter expert for several information systems and support inspections related to computerized systems.

Approves protocols, reports, investigations and other records on behalf of QC.

Monitors industry trends to ensure alignment with industry standard and, if necessary, modification of existing practices to reduce compliance risk.

Organizes and leads periodic review of existing processes.

May indirectly supervise lower-level QC Application Specialists and Analysts, as needed.

Requirements

Minimum Requirements:

Education

Bachelor’s Degree in Scientific / Biotech / Pharmaceutical / IT field of study

Experience

Senior Application Analyst

•             3+ years of laboratory related and/or information management work experience.

Application Specialist

•             6+ years of laboratory related and/or information management work experience.

Senior Application Specialist

•             8+ years of laboratory related and/or information management work experience.

Skills and Abilities:

Senior Application Analyst

•             High degree of organization and flexibility with ability to prioritize responsibilities as needs require.

•             Frequent inter-organizational and outside customer contacts.  Represents the organization in providing solutions to difficult technical issues associated with specific projects.

•             Provides solutions to a variety of technical problems of moderate scope and complexity.

•             Understanding of technical principles, theories, and concepts in the field.  General knowledge of other related disciplines.

•             Works under limited supervision.  Follows established procedures to perform job requirements.  No instructions needed on a routine basis. General instructions required to perform new activities or special assignments.  Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.

Application Specialist

•             All skills listed under Senior Application Analyst and those listed below.

•             Complete understanding and wide application of technical principles, theories, and concepts in the field and some other related disciplines.

•             Provides solutions to a variety of technical problems of moderate scope and high complexity.

•             Accomplishes tasks mainly as an individual contributor, but also provides technical guidance to less experienced staff and may have supervisory responsibility.

•             LIMS administration experience required.

Senior Application Specialist

•             All skills listed under Senior Application Analyst and those listed below.

•             Provides solutions to a variety of technical problems of high scope and complexity.

•             Works under general direction.  No instructions needed on a routine basis. Conduct investigation and solve problems independently.

•             Administration experience of a variety of computerized systems required.

•             Experience launching new quality software systems, preferably LIMS.

Preferred Experience/Skills:

Senior Application Analyst

•             LIMS administration experience desired.

Application Specialist

•             3+ years of LIMS administration experience desired.

•             Familiarity and understanding of electronic data integrity principles.

•             Experience launching new quality software systems, preferably LIMS.

Senior Application Specialist

•             5+ years of administration of LIMS and other computerized systems.

•             Thorough understanding of electronic data integrity principles.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

*LI-MEDI

~BSP